A Prospective Cohort Study of Patients with Hepatobiliary Cancer Treated with Immune Checkpoint Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Although immune checkpoint inhibitors including nivolumab and pembrolizumab are now available for the management of hepatobiliary cancers in Korea, there is a lack of data for the efficacy and safety of these agents in the real-world setting. This study aims to prospectively evaluate the efficacy of safety of nivolumab and pembrolizumab against advanced hepatocellular carcinoma and biliary tract cancer.
详细描述
Nivolumab 3 mg/kg intravenous every 2 weeks has been recently approved by US FDA for the management of patients with sorafenib-failed advanced HCC based on the promising data of Checkmate-040 phase I/II study. Although there is a lack of prospective data for pembrolizumab in biliary tract cancer except for small phase 1 trial, pembrolizumab is now available for use in Korea for the management of advanced biliary tract cancer. Because the approval of these agents was based on the small sample size, further prospective evaluation of nivolumab or pembrolizumab in patients with hepatobiliary cancer is needed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer) or hepatocellular carcinoma
- •Planned immune checkpoint inhibitors including nivolumab or pembrolizumab
- •Written informed consent
排除标准
- •Not available for the treatment with immune checkpoint inhibitors
研究组 & 干预措施
Hepatocellular carcinoma
Hepatocellular carcinoma patients treated with nivolumab
干预措施: Nivolumab or pembrolizumab (Drug)
Biliary Tract Cancer
Biliary tract cancer patients treated with pembrolizumab
干预措施: Nivolumab or pembrolizumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: 6 months
Proportion of complete response and partial response according to the Response Evaluation Criteria in Solid Tumors version 1.1
次要结局
- Adverse events(6 months)
研究者
Changhoon Yoo
Assistant Professor
Asan Medical Center